510(k) Report

Devices descending from K023357

480 later devices reach Arcpm 1050 Resin-Hips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+5K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+5K190057DJO Acetabular SystemEncore Medical L.P.201925
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+5K181947Persona Revision Knee SystemZimmer, Inc.201841
+5K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+5K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+5K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+5K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+5K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+5K161592Persona Partial Knee SystemBiomet, Inc.201652
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K153657Vanguard XP Knee SystemBiomet, Inc.201611
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+5K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+5K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+5K143635KINETIS Total Knee SystemMako Surgical20150—
+5K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+5K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+5K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+5K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+5K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+5K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+5K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+5K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+5K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+5K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+5K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+5K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+5K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+5K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+5K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+5K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+5K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K123692Pipeline Knee SystemPipeline Orthopedics20130—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+5K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K121727Movation Knee SystemEncore Medical L.P.201214—
+5K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+5K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International201114—
+5K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109—
+5K103120Corin Biolox Delta Femoral HeadsCorin USA2011110—
+5K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009149—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+6K261453G7® Acetabular SystemZimmer Biomet20260—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K262057GMK ExtensionMedacta International SA20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+6K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+6K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+6K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+6K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K251834Persona Partial KneeZimmer Biomet20250—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+6K243809Biolox® Delta Revision headsLimacorporate20250—